NCT01204684CompletedPhase 2
Dendritic Cell Vaccine for Patients With Brain Tumors
A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
Source: ClinicalTrials.gov · Last updated 28 Aug 2024
Brief summary (registry, in English)
The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 16 Sept 2010
- Start date
- Oct 2010
- Primary completion date
- Aug 2024
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Glioblastoma
- NCT number
- NCT01204684
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 24
- From Oct 2010 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with an active infection.
- Inability to obtain informed consent because of psychiatric or complicating medical problems.
- Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
- History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy.
- Subjects who have an uncontrolled systemic malignancy that is not in remission.
Other
- Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
- Subjects with organ allografts.
- Inability or unwillingness to return for required visits and follow-up exams.
Who the study is looking for
- Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)} will be eligible for this protocol.
- Patients must have had surgical resection at UCLA (University of California, Los Angeles), for which a separate informed consent was signed for the collection of their tumor prior to surgery.
- After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
- Patients must be 18 years or older and able to read and understand the informed consent document. Patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
- Patients must have a Karnofsky performance status (KPS) rating of \> 60 prior to initiating treatment. Patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \> 60 by the initiation of treatment.
Criteria the registry did not label
- PATIENT ELIGIBILITY
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Los Angeles, California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.